FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Acne Light Therapy Wand
K Number: K160691
·
Decision Jun 21, 2016
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
50
Applicant Total
1
Review Days
102
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Basic Information
- Device Name
- Acne Light Therapy Wand
- K Number
- K160691
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zuko, Inc.
- Date Received
- March 11, 2016
- Decision Date
- June 21, 2016
- Product Code
- OLP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OLP | Over-The-Counter Powered Light Based Laser For Acne | FDA class 2 | General, Plastic Surgery |
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